A Safety Study of ARRY-403 in Patients With Type 2 Diabetes

August 29, 2012 updated by: Array BioPharma
This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36 patients from the US will be enrolled in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Profil Institute for Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Male or female with willingness and ability to use protocol-specified methods of contraception, except females of nonchildbearing potential.
  • Diagnosis of Type 2 diabetes less than 5 years prior to study start.
  • HbA1c ≥ 6.5% and ≤ 10%.
  • BMI ≥ 25 and ≤ 40.0 kg/m2.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Recent history (i.e., less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia.
  • History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
  • Active infectious diseases including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Past history and inactive hepatitis B and C, as confirmed by serological testing, are allowed.
  • A positive test for drugs or alcohol.
  • Women who are pregnant or breastfeeding.
  • Donation or loss of ≥ 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug.
  • Additional criteria exist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo; oral
matching placebo
Experimental: ARRY-403
Drug: ARRY-403, glucokinase activator; oral
single dose, escalating

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time Frame: Duration of study
Duration of study
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
Time Frame: Day 1, Day 2
Day 1, Day 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Time Frame: Day 1, Day 2
Day 1, Day 2
Assess the ability of the study drug to improve glucose tolerance as determined by blood glucose monitoring during a standardized meal challenge.
Time Frame: Day 1, Day 2
Day 1, Day 2
Assess the excretion of the study drug and metabolites in urine following dosing.
Time Frame: Day 1, Day 2
Day 1, Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Array BioPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 30, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARRAY-403-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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